The Center of Medical Device Evolution is China, CMDE, has released a regulation (notification 53) for the supervision and administration of customized medical devices, including 3D-printed implantable devices for orthopedic and dental applications. It states that customized medical devices will be only available to medical institutions that issue orders for special needs for the purpose of designated patients and cannot used by non-order institutions or non-designated patients.
No 53. clarifies the registration dossier rational, device naming method, qualification of manufacturer and medical institution, design control, quality control, trace management, use management, and supervision management.
MAIN POINTS OF NO.53:
• 3D printing device would be validated and controlled in various aspects: production and verification processes, manufacturing process, post-treatment, testing of raw materials and final products, as well as cleaning, packaging and sterilization.
• The qualification of medical institution for conducting surgery must be approved by NMPA.
• Before using device, clinician, patient, and manufacturer needs to sign three-party contract.
•non-replaceable device which qualified subjects are rare, cohort research with 10-20 subjects could be conducted, with a comprehensive analysis with historical data.
NEW SUBMISSION DOSSIER SECTIONS:
- Customized device application form
- Declaration for necessity for manufacturing the customized device
- Product research material
- Product risk analysis material
- Manufacturing information
- Clinical application plan
- IRB opinion
- Contract of manufacturer with medical institution
- Administrative information
- Declaration of conformity